FDA releases method for detection and quantification of both NDMA and NDEA

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October 12, 2018

FDA releases method for detection and quantification of both NDMA and NDEA

FDA has redeveloped a testing method in order to detect the presence of the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in valsartan drug products.

FDA has redeveloped a testing method in order to detect the presence of the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in valsartan drug products. A previously posted combined gas chromatography-mass spectrometry (GC/MS) method was used for the detection of NDMA in valsartan products; however, that method was reworked following detection of NDEA in valsartan products manufactured by Zhejiang Huahai Pharmaceuticals. FDA noted it is also working to develop a GC/MS direct injection method for detection of NDMA and NDEA, and will post that information when it is available. More information about the combined GC/MS headspace method for detecting NDMA and NDEA is available here.